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er von á 3. stigs prófunum á bóluefni mRNA-1273 frá Moderna.

"CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 27, 2020-- Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2) to evaluate mRNA-1273 in Phase 2 and late-stage studies if supported by safety data from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which is expected to begin in the second quarter of 2020. This study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. Each subject will be assigned to receive placebo, a 50 μg or a 250 μg dose at both vaccinations. The company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Participants will be followed through 12 months after the second vaccination.

“Submitting this IND is an important next step in the clinical development of our mRNA vaccine against SARS-CoV-2, and we are moving rapidly to potentially address this global health emergency,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “We look forward to launching this Phase 2 study as soon as possible, which will provide important information about the safety, reactogenicity and immunogenicity of mRNA-1273.”

Subject to data from the Phase 1 and Phase 2 studies and discussions with regulators, a Phase 3 study could begin in the fall of 2020. Funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, supported the planning for these studies and also will support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing.

“Safe, effective vaccines are critical to ending this pandemic and preventing future outbreaks of SARS-COV-2,” said BARDA Acting Director Gary Disbrow, Ph.D. “The next steps announced today for this particular vaccine highlight the value of collaboration among government agencies including BARDA and NIAID, and the private sector, to move vaccines and other medical countermeasures forward as rapidly as possible.”"

Þangað til gerist líklega lítið nema "bein og dauð". Allur heimurinn er í klessu. Við getum hjarað svona eitthvað á fiskinum ef einhver getur keypt. Allt annað er í klessu og verður það út árið. 

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Athugasemdir

1 Smámynd: Halldór Jónsson

Dr. Anthony Fauci, the nation’s top infectious disease expert, on Tuesday said he was “cautiously optimistic” that a vaccine to stop the coronavirus will be known “by this coming winter”.

“Hopefully by the time we get to this coming winter, we will know whether or not we have a safe and effective vaccine,” Fauci said, during a discussion sponsored by the Economic Club of Washington,

This would not be the last step in getting the vaccine ready, he noted. Once it is found that a vaccine is safe and effective on humans, the challenge will be to scale the vaccine up so there are enough doses for everyone, not just rich countries, Fauci said.

Asked about a report that researchers at Oxford University have developed a vaccine that has worked in monkeys, Fauci replied: “There are going to be a lot of candidates out there.”

 

“Hopefully we can move along rather rapidly to get an answer ‘are they are safe and effective?’,” Fauci said.

The doctor is sticking with his initial prediction, made in early April, that a COVID-19 vaccine could take 12 to 18 months to develop, test, and approve for human use. At the time, many experts said this timeline was unrealistic.

Fauci said he was “almost certain” the coronavirus will come back next winter.

“It is not going to disappear from the planet. Which means as we get into next season, in my mind, its inevitable that we will have a return of the virus,” Fauci said.

Halldór Jónsson, 29.4.2020 kl. 20:08

2 Smámynd: Halldór Jónsson

Vonandi fara menn að veita sóðaskapnum í Kína athygli.Það verður að gera ráðstafanir til aukins hreinlætis um allan heim.

Halldór Jónsson, 29.4.2020 kl. 21:36

3 Smámynd: Halldór Jónsson

They had expected it to be presented simultaneously in a detailed news release, a briefing at a medical meeting or in a scientific journal, allowing researchers to review the data. Information from various trials of remdesivir has been leaked to media in recent weeks. In a statement on Wednesday, Gilead said the NIAID's much anticipated trial had met its primary goal, but gave no details.

Data in a separate NIAID statement after Fauci spoke detailed preliminary results showing that patients who got the drug had a 31 percent faster time to recovery than those who got a placebo, cutting hospital stays by four days.

Halldór Jónsson, 30.4.2020 kl. 10:50

4 Smámynd: Halldór Jónsson

Dr.Fauci lét taka þá sem voru á lyfleysum af þeim og byrja að taka Remdesivir af augl´jósum ástæðum.

Halldór Jónsson, 30.4.2020 kl. 10:52

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Halldór Jónsson
Halldór Jónsson

verkfræðingur, flugdellukall, tennis-og badmintonspilari

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